Chapter 1

Question 1

What is the name of the law governing the Florida drug distribution companies?

Answer 1

Florida Drug and Cosmetic Act

Question 2

What is the purpose of the Florida Drug and Cosmetic Act?

Answer 2

Safeguard the public health and promote the public welfare by protecting the public from injury by product use and by merchandising deceit involving drugs, devices, and cosmetics.

Question 3

What is “active pharmaceutical ingredient”?

Answer 3

includes any substance or mixture of substances intended, represented, or labeled for use in drug manufacturing that furnishes or is intended to furnish, in a finished dosage form, any pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, therapy, or prevention of disease in humans or other animals, or to affect the structure or any function of the body of humans or animals.

Question 4

“Affiliate”

Answer 4

means a business entity that has a relationship with another business entity in which, directly or indirectly:

Question 5

The business entity…

Answer 5

…controls, or has the power to control, the other business entity;

Question 6

A third party controls…

Answer 6

…or has the power to control, both business entities.

Question 7

“Affiliated party” means…

Answer 7

-A director, officer, trustee, partner…
-A person who has filed or is required to file a personal information statement …
-The five largest natural shareholders that own at least 5 percent of the permittee or applicant.

Question 8

“Contraband prescription drug” means…

Answer 8

any adulterated drug, as defined in s. 499.006, any counterfeit drug, as defined in this section, and also means any prescription drug for which a transaction history, transaction information, or transaction statement does not exist, or for which the transaction history, transaction information, or transaction statement in existence has been forged, counterfeited, falsely created, or contains any altered, false, or misrepresented matter.

Question 9

“Counterfeit drug”

Answer 9

…without authorization, bears the trademark, trade name, or other identifying mark, imprint…which thereby falsely purports or is represented to be the product…

Question 10

“Department”

Answer 10

means the Department of Business and Professional Regulation.

Question 11

“Distribute” or “distribution”

Answer 11

means to sell, purchase, trade, deliver, handle, store, or receive. The term does not mean to administer or dispense.

Question 12

“Drug” means an article that is:

Answer 12

Recognized in the current edition of the United States Pharmacopoeia and National Formulary…

Question 13

“Establishment” means…

Answer 13

a place of business which is at one general physical location and may extend to one or more contiguous suites, units, floors, or buildings operated and controlled exclusively by entities under common operation and control. Where multiple buildings are under common exclusive ownership, operation, and control, an intervening thoroughfare does not affect the contiguous nature of the buildings. For purposes of permitting, each suite, unit, floor, or building must be identified in the most recent permit application.

Question 14

“Labeling”

Answer 14

means all labels and other written, printed, or graphic matters:

Question 15

“Manufacturer” means:

Answer 15

-A person who holds a New Drug Application, an Abbreviated New Drug Application
-A co-licensed partner of the person described in paragraph
-An affiliate of a person described in paragraph (a), paragraph (b)
-A person who manufactures a device or a cosmetic.

Question 16

“Medical convenience kit”

Answer 16

means packages or units that contain combination products as defined in 21 C.F.R. s. 3.2(e)(2).

Question 17

“Medical gas”

Answer 17

means any liquefied or vaporized gas that is a prescription drug

Question 18

“New drug”

Answer 18

Unapproved drug

Question 19

“Repackage”

Answer 19

includes repacking or otherwise changing the container, wrapper, or labeling to further the distribution of the drug, device, or cosmetic.

Question 20

“Repackager”

Answer 20

means a person who repackages. The term excludes pharmacies that are operating in compliance with pharmacy practice standards as defined in chapter 465 and rules adopted under that chapter.

Question 21

When can a wholesaler repackage?

Answer 21

Can’t in any way.

Question 22

“Wholesale distribution” means

Answer 22

the distribution of a prescription drug to a person other than a consumer or patient, or the receipt of a prescription drug by a person other than the consumer or patient, but does not include:
-charitable organization
-The distribution of a prescription drug among hospitals or other health care entities that are under common control
-federal, state, or local government agency
-emergency medical reasons
-reverse distributions or destruction

Question 23

the hospital or health care entity that distributes prescription drugs pursuant to this subparagraph must reconcile all drugs distributed and returned and resolve any discrepancies in a timely manner.

Answer 23

-Intracompany distribution of any drug between members of an affiliate or within a manufacturer.
-distribution of prescription drug samples
-distribution of a prescription drug by a third-party logistics provider
-The distribution of an intravenous prescription drug that, by its formulation, is intended for the replenishment of fluids and electrolytes, such as sodium, chloride, and potassium or calories, such as dextrose and amino acids.
-The distribution of an intravenous prescription drug used to maintain the equilibrium of water and minerals in the body, such as dialysis solutions.
-The distribution of a prescription drug that is intended for irrigation or sterile water, whether intended for such purposes or for injection.
-The distribution of an exempt medical convenience kit pursuant to 21 U.S.C. s. 353(e)(4)(M).
-A common carrier that transports a prescription drug, if the common carrier does not take ownership of the prescription drug.
-The distribution of medical gas pursuant to part III of this chapter.

Question 24

“Authorized absence”

Answer 24

the physical absence of the designated representative from the permitted establishment, for a cumulative 60 calendar days in any 365 calendar day period for situations such as: the birth of the employee’s child and to care for the newborn child; the placement of a child with the employee for adoption or foster care; the care of a family member (child, spouse, or parent) with a health condition, where the employee is needed to care for the family member; or the employee’s own serious health condition makes the employee unable to perform the functions of the designated representative.

Question 25

“Authorized recipient”

Answer 25

means a person permitted by or otherwise authorized by Florida law, or by the law of the jurisdicition in which the person receives the prescription drugs

Question 26

“Broker”

Answer 26

means a person participating in the wholesale distribution of a prescription drug by buying, purchasing, or otherwise taking ownership of or title to the prescription drug and selling or transferring, or offering to sell or transfer, ownership of or title to the prescription drug to a person other than the patient or the patient’s agent without taking physical possession of the prescription drug.

Question 27

“Change in Ownership”

Answer 27

transfer or assignment of a majority of the direct ownership or controlling interest of a permitted establishment…more than 50%.

Question 28

“Intracompany transfer”

Answer 28

between two establishments wholly owned and operated by the same business entity.

Question 29

“Readily available” and “readily retrievable”

Answer 29

mean that records, either hard copy or computerized, are organized in such a manner that they can be quickly and easily retrieved during an inspection; individual records can be produced within minutes of the request (unless the permitted address is not within the state in which case a 48 hour timeframe is available for producing records). Required records that are kept by automatic data processing systems or other electronic or mechanized recordkeeping systems are kept in such a manner so that they can be separated out from all other records in a reasonable time.

Question 30

“Repackaging or otherwise changing the container, wrapper, or labeling to further the distribution” means:

Answer 30

1. Altering a packaging component that is or may be in direct contact with the drug, device, or cosmetic. For example, repackaging from bottles of 1000 to bottles of 100.
2. Altering a manufacturer’s package for sale under a label different from the manufacturer. For example, a kit that contains an injectable vaccine from manufacturer A; a syringe from manufacturer B; alcohol from manufacturer C; and sterile gauze from manufacturer D packaged together and marketed as an immunization kit under a label of manufacturer Z.
3. Altering a package of multiple-units, which the manufacturer intended to be distributed as one unit, for sale or transfer to a person engaged in the further distribution of the product. This does not include:

Question 31

“Repackaging or otherwise changing the container, wrapper, or labeling to further the distribution” DOES NOT include…

Answer 31

a. Selling or transferring an individual unit which is a fully labeled self-contained package that is shipped by the manufacturer in multiple units, or
b. Selling or transferring a fully labeled individual unit, by adding the package insert, by a person authorized to distribute prescription drugs to an institutional pharmacy permit, health care practitioner or emergency medical service provider for the purpose of administration and not for dispensing or further distribution.

Question 32

“Rx”

Answer 32

means prescription

Question 33

“Sale”

Answer 33

includes any transfer of title or ownership whether by barter, exchange or gift.

Question 34

“State Current Good Manufacturing Practices” means

Answer 34

current good manufacturing practices

Question 35

“Unapproved new drug”

Answer 35

means any drug which has not been approved

Question 36

Wholesale Distribution of Prescription Drugs – Exceptions…”emergency medical reasons” includes…

Answer 36

-Transfers of a prescription drug between health care entities or from a health care entity to a retail pharmacy to alleviate a temporary shortage
-emergency transport vehicle
-alleviate a temporary shortage